Medical Device Manufacturer · US , Echo , OR

Samsung Electronics Co., Ltd. - FDA 510(k) Cleared Devices

40 submissions · 39 cleared · Since 2013

40

Total

39

Cleared

1

Denied

33 devices

26-33 of 33

Cleared Dec 17, 2014

GM60A-32S, GM60A-40S

Radiology · 104d

Cleared May 29, 2014

Radiology · 108d

Cleared May 28, 2014

Radiology · 107d

Cleared May 28, 2014

Radiology · 107d

Cleared May 15, 2014

Radiology · 105d

Cleared Jun 20, 2013

DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A

Radiology · 261d

Cleared Jun 07, 2013

Radiology · 248d

Cleared Jan 18, 2013

Radiology · 108d